Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders

NCT05483270 | Completed DMC

• 1 other identifier: Delay-ET-RCT
• Study Type: interventional
• Target: 845
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomised controlled trial. The investigators plan to randomise 836 participants to the immediate FET or the postponed FET from the day of oocyte retrieval to the last day of that menstrual cycle in a 1:1 rate. Primary outcome will be the live birth rate after the embryo transfer.

Conditions

IVF

Outcome Measures

Primary Outcomes (1)

• Live birth after the first embryo transfer

  Live birth is defined as the delivery of at least one baby after 22 weeks of gestation that exhibits any sign of life.

  At least 22 months gestation after the first embryo transfer cycle

Secondary Outcomes (16)

• Clinical pregnancy

  around 7 weeks' gestation after the first embryo transfer cycle

• Ongoing pregnancy

  12 weeks' gestation or beyond after the first embryo transfer cycle

• Biochemical pregnancy

  about 12 days after embryo transfer

• Ectopic pregnancy

  about 6 weeks after embryo transfer

• Miscarriage

  6-22 weeks of gestation

Study Arms (2)

Immediate FET group

ACTIVE COMPARATOR

Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval.

Biological: the timing of embryo transfer in freeze-all cycles

Postponed FET group

EXPERIMENTAL

Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval.

Biological: the timing of embryo transfer in freeze-all cycles

Interventions

the timing of embryo transfer in freeze-all cycles BIOLOGICAL

Immediate FET group Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval. Postponed FET group Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval.

Immediate FET group; Postponed FET group

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 20 to 42 years old;
• Written informed consent;
• Women scheduled for freeze-all embryo transfer;
• Women with the number of oocyte collected higher than 15.

You may not qualify if:

• Women with a history of at lease three failed transfer cycles;
• Women with an endometrial thickness less than 7 mm on the triggering day;
• Severe uterine malformations.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Women's Hospital School Of Medicine Zhejiang University: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Shengjing Hospital: collaborator

Study Sites (1)

Peking university third hospital

Beijing, 100191, China

Location

Study Officials

• Kai-Lun Hu, M.D

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 2, 2022
• Study Start: August 30, 2022
• Primary Completion: October 8, 2024
• Study Completion: November 24, 2024
• Last Updated: November 27, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The day of publishing the main results. Around 3 years from now
• Access Criteria: Please contact the hukailun@bjmu and roseli001@sina.com

Locations

CN (1)